Kornimate/medical-research-clean huggingface dataset:
rotation or change of biotherapy after first anti-tnf treatment failure for rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: approximately 30% of patients with rheumatoid arthritis have an inadequate response to anti-tnf (primarily or loss of response), leaving two alternatives: rotation to a second anti-tnf or change of biologic, with a different mechanism of action, such as abatacept, rituximab and tocilizumab. no controlled trial compared these two strategies face to face. the present objective is to investigate the issue whether one of these strategies could have a better efficacy in a pragmatic trial in the setting of current practice.


Eligibility criteria:
inclusion criteria: * active and erosive rheumatoid arthritis with a das28 equal or greater than 3.2 * inadequate response to a 1st anti-tnf * stable or no treatment with any dmards, or oral corticosteroids (\< or = to 10 mg/day of prednisone equivalent)during the preceding month exclusion criteria: * counter-indication to other anti-tnf, abatacept, rituximab or tocilizumab * pregnancy * age \< 18 years * impossibility to give informed consent * impossibility to be followed for 12 months

Keywords: rheumatoid arthritis with inadequate response to 1 anti-tnf
polyp artificial intelligence study

Conditions: Software Analysis on Polyp Histology Prediction

Summary: background we are developing artificial intelligence based polyp histology prediction (aiphp) method to automatically classify narrow band imaging (nbi) magnifying colonoscopy images to predict the non-neoplastic or neoplastic histology of polyps. aim our aim was to analyse the accuracy of aiphp and nice classification based histology predictions and also to compare the results of the two methods. methods we examined colorectal polyps obtained from colonoscopy patients who had polypectomy or endoscopic mucosectomy. polyps detected by white light colonoscopy were observed then by using nbi at the optical maximum magnificent (60x). the obtained and stored nbi magnifying images were analysed by nice classification and by aiphp method parallelly. pathology examinations were performed blinded to the nice and aiphp diagnosis, as well. our aiphp software is based on a machine learning method. this program measures five geometrical and colour features on the endoscopic image.


Eligibility criteria:
inclusion criteria: * endoscopic diagnosis of colorectal polyp exclusion criteria: * colonoscopy result without polyps or ibd diagnosis
spinal cord stimulation (scs) for neuropathic pain of back or lower extremity

Conditions: Intractable Neuropathic Pain; Pain; Back Pain; Lower Extremity Pain

Summary: the primary objective of this study is to compare the efficacy and patient preference for spinal cord stimulation (scs) using the precision device with the electrode array placed at t7 versus placement at t8. eligible patients will have chronic intractable pain in the back or lower extremities and will have independently elected scs as the next line of therapy. there is some anecdotal evidence that the coverage of the paresthesia resulting from t7 placement is preferable to that obtained by the more commonly used t8 placement but there has been no study to support this observation.

the conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed at t8-t9 vertebral levels. recently published studies as outlined in a letter to the editor of neuromodulation suggest that a "well placed single lead will generally perform better than a dual lead." furthermore, anecdotal reports suggest that lead placement at t7 will capture axial back pain with greater success compared to lead placement at alternative sites. this study aims to achieve better pain treatment and paresthesia coverage by placing a single lead at t7.

Eligibility criteria:
inclusion criteria: * be diagnosed with chronic intractable neuropathic pain of moderate to severe intensity of the back or lower extremity and meeting the criteria for post-laminectomy syndrome, be eligible for scs, and have independently elected scs as next line of therapy. * be 18 years of age or older. * be willing and able to comply with all study related procedures and visits. * be capable of reading and understanding patient information materials and giving written informed consent. exclusion criteria: * have sensory loss in the low back or lower extremity as the primary complaint. * have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints. * have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other study during the year.

Keywords: pain chronic pain neurostimulation
the safety and efficay investigation of car-t cell therapy for patients with hematological malignancies

Conditions: Acute Lymphoblastic Leukemia; Lymphoma; Multiple Myeloma

Summary: to evaluate the tolerability and safety of car-t technology in patients with relapsed or refractory hematolymphoid malignancies.

main research purposes: to evaluate the tolerability and safety of car-t technology in patients with relapsed or refractory hematolymphoid malignancies. secondary research purposes: objective evaluation of cytodynamic characteristics of car-t in different types of hematological malignancies

Eligibility criteria:
inclusion criteria: * sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet; * diagnosed as recurrent or refractory lymphoma, leukemia or myeloma; * tumor cells express targets for car-t cell therapy (results: flow cytometry or immunohistochemical test confirmation); * age 14-75 (including threshold), gender unlimited; * eastern cooperative oncology group (ecog) score ≤2; * hgb ≥ 70g/l (blood transfusion allowed); * liver and kidney functions, heart and lung functions meet the following requirements: 1. creatinine ≤ 1.5 × uln; 2. left ventricular ejection fraction ≥ 50%; 3. blood oxygen saturation\>90%; 4. total bilirubin ≤ 1.5 × uln； alt and ast ≤ 2.5 × uln; * for t cell tumor patients, if tumor cells are detected in peripheral blood during screening, flow cytometry should be used to detect that the tumor cell surface immunophenotype is cd4 and cd8 double negative. if the immunophenotype of peripheral blood tumor cells is not double negative for cd4 and cd8, the condition that the proportion of peripheral blood tumor cells is ≤ 1% shall be met; * subjects with pregnancy plans must agree to use contraception before entering the study and after the study lasts for six months; if the subject is pregnant or suspected of being pregnant, the investigator shall be informed immediately; * the subject or guardian understands and signs the informed consent form; * expected survival longer than 3 months. exclusion criteria: * severe cardiac insufficiency; * have a history of severe lung impairment; * complicated with other advanced malignant tumors; * complicated with severe or persistent infection that cannot be effectively controlled; * complicated with severe autoimmune diseases or congenital immune deficiency; * active hepatitis (hbv dna or hcv rna positive); * human immunodeficiency virus (hiv) infection or syphilis infection; * have a history of severe allergy to biological products (including antibiotics); * if there is a history of hematopoietic stem cell transplantation, it should be no more than 6 months before the patient receives allogeneic hematopoietic stem cell transplantation; * subjects who received car-t therapy or other gene modified cell therapy before screening; * conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.

Keywords: cd19,cd20,bcma b-all/mm/nhl
intestinal microbiota and postoperative ileus after colorectal surgery

Conditions: Postoperative Ileus; Surgery-Complications

Summary: postoperative ileus (poi) after colorectal surgery is frequent and is a burden for national health authority because it increases the morbidity and the length of hospital stay. some of the stage of the mechanism of poi are known and are now targeted to reduce its occurence but despite these measures, poi still happens in 10-30% of surgeries. the role of the intestinal microbiota in poi is unknown while it could be a new target to reduce its duration or its occurence.


Eligibility criteria:
inclusion criteria: * laparoscopic colorectal resection with anastomosis and without diverting stoma exclusion criteria: * risk of modification of the microbiota (terminal enterostomy, chronic inflammatory bowel disease, oesophageal or gastric surgery, vagal nerves lesion, beta lactamin allergy, bowel cleansing) * postoperative complication
comparison of interventions for developmental dyslexia

Conditions: Developmental Dyslexia

Summary: the purpose of the present study is to compare the effectiveness of rhythmic reading training (rrt), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and that of an intervention resulting from the combination of two yet validated treatments for dd, namely, bakker's visual hemisphere-specific stimulation (vhss) and the action video game training (avg). finally, the effectiveness of the administration of only avg is intended to be compared to other treatments. all interventions are administered for 13 hours over 9 days to a group of italian students with dd aged 8-12.


Eligibility criteria:
inclusion criteria: * having been diagnosed with dd (icd-10 code: f81.0) on the basis of standard inclusion and exclusion criteria (icd-10: world health organization, 1992) and of the diagnosis procedure followed in the italian practice exclusion criteria: * presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed) * having been involved in previous reading intervention programs

Keywords: reading developmental dyslexia, music rhythm action video games hemisphere-specific stimulation
assessment of volumetric hemodynamic parameters and nutritional status in stable renal transplant recipients

Conditions: Cardiac Output, Low; High Blood Pressure

Summary: changes in volumetric hemodynamic parameters and fluid overload (cardiac index,stroke volume, thoracic fluid content, systemic vascular resistance) were measured using a impedance cardiography (icg) (cardioscreen 1000 - haemodynamic measurement system, medis. ilmenau) in stable renal transplant recipients nutritional status was measured by tanita 418 monitor.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * functioning graft longer than 3 months to 10 years * no clinical cardiovascular disease during the 6 months preceding entry * stable graft function- glomerular filtration rate \> 30 ml/min/1.73 m2, creatinine concentration \<2.5 mg/dl * medical staff (medical doctors, nurses) exclusion criteria: * not meet the above criteria * episode of illness (for example: infection) * pregnancy

Keywords: impedance kidney transplantation
electric pace-pitched hearing achieves natural tonotopy

Conditions: Deafness

Summary: in search of the best possible outcome for the severe hearing impaired who have regained the ability to hear by means of a cochlear implant (ci), electrical stimulation and the information it carries should match as closely as possible to what the human brain naturally has evolved to cope with and learned to process instead of relying on plasticity to adapt to an induced mismatch. at the moment, however, ci's are fitted with a 'one size fits all' principle. this is known to cause a mismatch between the frequencies presented by the ci electrode array and the frequencies represented at the corresponding natural acoustic location in an individual cochlea. in this study it is hypothesized that an individual imaged based fitting that pursues natural hearing alignment and is implemented from the start of the rehabilitation process, will improve the individual outcomes of electric hearing. the natural fitting strategy is thought to give rise to a steeper learning curve, result in a better performance in challenging listening situations, improve sound quality, complement better with residual acoustic hearing in the contralateral ear and win the preference of ci-recipients.


Eligibility criteria:
inclusion criteria: * adult (18y or older) and meeting the conventional dutch ci criteria; * proficient speaker of dutch language; * post-lingual onset of profound deafness (\> 4 years of age); * subject receives an advanced bionics implant with midscala electrode and an advanced bionics sound processor; * prepared to use study specific hearing aid (phonak) for the duration of the study; * rehabilitation at mumc+ for the first year after surgery regarding ci as well as ha; * active participation in trial related procedures such as daily randomization and regular testing. exclusion criteria: * physical or non-physical contraindications for mri or ct imaging; * additional disabilities that may prevent active participation and testing as per protocol. if there are indications that the mental abilities to comply with the study procedures are insufficient, additional screening will be performed with the mini-mental state examination. patients will be excluded from the study when the resulting score is lower than 24; * cochlear or neural abnormalities that could affect outcome measures and/or compromise the placement of the electrode as assessed by the ci surgeon; * active participation in another prospective clinical trial; * pregnancy at time of imaging; * requirement for electric-acoustic activation prior to the first year follow-up; * having received a cochlear implant earlier (e.g. explantation or bilateral implantation).
bioavailability study comparing modified release to immediate release apixaban tablets in healthy volunteers

Conditions: Thrombosis

Summary: to estimate the pharmacokinetics of apixaban when administered as three different modified release formulation tablets relative to that when apixaban is administered as an immediate release tablet


Eligibility criteria:
inclusion criteria: * healthy male or female patients * body mass index (bmi) of 17.5 to 30.5 kg/m2 exclusion criteria: * any condition possibly affecting drug absorption * history or evidence of abnormal bleeding or clotting disorder

Keywords: formulation; sustained release; modified release; extended release
internet-based cognitive behavioral therapy in inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Psychological Distress

Summary: while people of color are an increasing segment of the inflammatory bowel disease (ibd) population, they are currently underrepresented in research, including studies of psychological distress. appreciation for psychological distress (anxiety, depression, perceived stress) as a driver of ibd activity has led to increased efforts to integrate psychological interventions into ibd medical care. cognitive behavioral therapy (cbt) is the most studied psychotherapeutic approach in ibd and the one that suggests improvements in mental health and quality of life in those with elevated psychological distress. there are unanswered questions in the use of cbt in ibd: how to leverage digital technology to deliver cbt through internet-based cognitive behavioral therapy (icbt); how do we consider the social context of individuals from racial and ethnic minority groups who may experience distinct social and structural barriers to acceptance and use of psychological interventions? thus, this study will qualitatively analyze how factors, such as digital access, mental health stigma, and lived experience with ibd and as racial or ethnic minority influence attitudes toward mental health and icbt in a cohort of black and latino ibd patients with elevated psychological distress. results will lead to adaptation of a cbt program into an icbt app to be tested for acceptance/use and to explore effects on psychological and disease-related factors.


Eligibility criteria:
inclusion criteria: * self-identify as black or hispanic/latino * diagnosis of crohn's disease or ulcerative colitis * ability to provide informed consent in english * basic computer skills (i.e. ability to self-complete online questionnaire) * elevated psychological distress exclusion criteria: * severe psychological distress * active suicidality, past suicide attempt, or psychiatric hospitalization
expanded use in persistent (b. microti) babesiosis

Conditions: Persistent Babesiosis

Summary: the purpose of this expanded access protocol is to offer a potentially effective treatment (tafenoquine) to patients with persistent babesiosis, who have not responded to standard of care treatments, and who are immunocompromised and thus at risk for more serious complications. tafenoquine will be self-administered orally as 2 x 100 mg dark pink coated tablets once daily (total daily dose 200 mg) with food on days 1, 2, 3 \& 4 then weekly thereafter (starting on day 11) until the patient has two consecutive negative pcr tests for babesia parasites and symptoms of babesiosis have resolved. other standard of care treatments recommended in the 2020 idsa guideline on diagnosis and management of babesiosis should also be included in the treatment regimen.


Eligibility criteria:
inclusion criteria: * male or female, aged ≥ 18 years * laboratory confirmed infection with b. microti and exhibiting clinical symptoms of babesiosis * able and willing to give written informed consent * able to take arakoda according to prescribing information * if female willing to take birth control for 90 days * have risk factors for relapsing disease * azithromycin, atovaquone, and/or clindamycin administered in the last 12 months to treat babesiosis, and, in the opinion of the investigator, high likelihood that current infection represents a relapse or continuation of disease * willing to initiate or continue a standard of care antimicrobial regimen exclusion criteria: * have any of the contraindications for arakoda * current or planned treatment with quinine while participating in the study * any concomitant significant illness unrelated to babesiosis * taking any excluded concomitant medication * the patient is unable to tolerate medication by the oral route
effect of transfer energy capacitive resistive therapy on shoulder pain and function in shoulder impingement syndrome

Conditions: Impingement Syndrome, Shoulder

Summary: this study investigates the efficacy of combining transfer energy capacitive and resistive (tecar) therapy with standard strengthening exercises in treating shoulder impingement syndrome (sis). a double-blinded randomized controlled trial will compare outcomes between patients receiving only strengthening exercises and those receiving both tecar therapy and exercises. key outcomes include improvements in pain, muscle strength, joint position sense, and shoulder function. the study aims to determine if tecar therapy enhances treatment benefits beyond those achieved with exercises alone.

background: shoulder impingement syndrome (sis) is a prevalent musculoskeletal condition characterized by pain and functional impairment due to the compression of rotator cuff tendons beneath the coracoacromial arch. despite the effectiveness of conservative treatments such as strengthening exercises, there is emerging interest in additional modalities, including transfer energy capacitive and resistive (tecar) therapy. tecar therapy utilizes high-frequency electromagnetic waves to provide deep thermal energy, potentially enhancing tissue repair and pain relief. objective: this study aims to evaluate the effectiveness of combining tecar therapy with a standard strengthening exercise regimen compared to strengthening exercises alone in patients with sis. methods: a double-blinded randomized controlled trial will be conducted with 30 participants diagnosed with neer's stage i sis. participants will be randomly assigned to either a control group receiving only strengthening exercises or an experimental group receiving both tecar therapy and strengthening exercises. the study will assess pain, shoulder muscle strength, joint position sense, and shoulder function using a range of validated instruments including the visual analogue scale (vas), hand-held dynamometer (hhd), digital inclinometer, and the shoulder pain and disability index (spadi).

Eligibility criteria:
inclusion criteria: * both gender age from 25-40 with a clinical diagnosis of neer's stage ii sis and body mass index (18.5-29.9) * shoulder pain for at least three months * painful arc of movement during flexion or abduction * positive neer's or kennedy- hawkins test or empty can test * pain on resisted external rotation, abduction exclusion criteria: * symptoms of cervical radiculopathy. * diagnosed inflammatory disorder. * neurological disorder. * widespread pain condition. * evidence of complete rotator cuff tear (positive drop arm test). * previous surgery to the affected shoulder. * noncompliance patient. * pacemaker.

Keywords: strengthening exercises shoulder impingement syndrome transfer energy capacitive and resistive
coated devices to decrease infection in the intensive care unit

Conditions: Critically Ill

Summary: pilot explanatory, randomized, open label, controlled trial. critically ill patients which will demand placement of invasive devices for organ support (endotracheal tube, central venous catheter and urinary foley catheter) will be randomized 1:1 to receive coated (bactiguard®) or habitual (non-coated) devices.


Eligibility criteria:
inclusion criteria: * all patients admitted to the intensive care unit which will require simultaneous insertion of all three devices (endotracheal tube, central venous catheter and urinary catheter) due to illness severity as defined by the attending physician. exclusion criteria: * patients admitted to the intensive care unit for more than 48 hours or admitted in the hospital for more than seven days * presence of any of the invasive devices (endotracheal tube, central venous catheter or urinary catheters) before randomization and absence of the intention to exchange the devices; * previous use of any type of coated devices; * age \< 18 years; * known pregnancy * known allergy to gold, silver and palladium; * suspected or confirmed brain death; * previously enrolled in the study newly added exclusion criteria in version 2.0: * severe chronic pulmonary obstructive disease which may limit catheter site selection * previous irradiation and/or thrombosis in site selected for catheter insertion

Keywords: sepsis ventilator-associated pneumonia catheter related bloodstream infection urinary catheter-related infection